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Trelagliptin succinate tablets

A technology of troxagliptin succinate and tablet, applied in the field of medicine, can solve the problems of slow disintegration and difficult absorption of tablets, and achieve the effects of good stability, easy operation and simple preparation method.

Inactive Publication Date: 2017-01-11
中山万远新药研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] CN201510269594.0 discloses a tablet of trexagliptin succinate, which overcomes the adverse phenomenon in the granulation process, but the tablet of the invention is not suitable for patients with dysphagia, and the amount of lubricant applied in the prescription is relatively large. Too much (2%-10%, preferably 2%-5%) causes the tablet to disintegrate slowly and is not easy to absorb quickly

Method used

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  • Trelagliptin succinate tablets
  • Trelagliptin succinate tablets
  • Trelagliptin succinate tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Desagliptin Succinate Tablet Prescription Screening

[0033] This experiment is an optimization design of the prescription of trexagliptin succinate tablet based on the Screen method, as follows:

[0034] 1. Risk assessment of Trexagliptin raw material

[0035] The properties of trexagliptin raw materials may have an impact risk assessment on the critical quality attributes (CQAs) of the preparation. Rank the relative risk assessed for each attribute as high, medium, or low. High-risk attributes require in-depth research in the preparation development process, thereby reducing the risk assessment level; medium risk assessment levels need to determine the acceptance of the current risk level or conduct appropriate research to reduce the risk according to the needs of the research; The CQAs of the formulation had basically no effect, and no further study was required. The following table 1 is based on the physical and chemical properties, biopharmaceutical pr...

Embodiment 2

[0068] The preparation of embodiment 2 trexagliptin succinate tablet

[0069] prescription

[0070]

[0071] Preparation method: mix troxagliptin succinate, croscarmellose sodium, hydroxypropyl cellulose, mannitol and microcrystalline cellulose evenly, pass through an 80-mesh sieve for later use, and carry out dry granulation through a dry granulator , to obtain dry granules; mix the dry granules with sodium stearyl fumarate evenly, and press into tablets.

Embodiment 3

[0072] The stability of embodiment 3 trexagliptin succinate tablet

[0073] The Trexagliptin succinate tablets prepared in Example 2 were placed under high temperature and high humidity conditions, and the related substances on day 0 and day 10 were investigated. The results are shown in Table 8.

[0074] Table 8 Stability of Trexagliptin Succinate Tablets

[0075]

[0076]

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Abstract

The invention provides trelagliptin succinate tablets and a preparation method thereof. The trelagliptin succinate tablets contain the following components in parts by weight: 64.0%-78.2% of trelagliptin succinate, 3.7%-5.0% of cross-linking sodium cellulose glycolate, 2.2%-5.0% of hydroxypropyl cellulose, 6.8%-25.1% of mannitol, 6.8%-15.2% of microcrystalline cellulose and 0.1%-5% of sodium stearoyl fumarate. The invention aims at providing the trelagliptin succinate tablets with even quality, high disintegration speed, good digestion degree, small tablet weight, simple production process, easy operation and suitability for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a tablet of trexagliptin succinate and a preparation method thereof. Background technique [0002] Type II diabetes is the main type of diabetes, accounting for more than 90% of all diabetic patients. With the development of economy, the improvement of living standards and the aging of population, the spectrum of human diseases is undergoing significant changes. Chronic non-communicable diseases have become a threat to human beings. The main reason for health. Type II diabetes is an endocrine and metabolic disease characterized by hyperglycemia. Its prevalence rate is increasing year by year. In addition, it has many complications, long treatment time and high treatment cost, which brings a heavy burden to the society. [0003] DPP-4 is an enzyme that triggers the inactivation of incretins (glucagon-like peptide-1, GLP-1) and diabetes-dependent insulinotropic polype...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/26A61K47/12A61K31/513A61P3/10
CPCA61K9/2054A61K9/2013A61K9/2018A61K31/513
Inventor 杜志博郑明泽王鹤然王佳平徐小林彭韪
Owner 中山万远新药研发有限公司
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